Autologous Cell Sheets Transplantation After ESD in the Esophagus
CellSheet2
Transplantation of Autologous Cell Sheets After Endoscopic Submucosal Dissection (ESD) for Early Adenocarcinoma of the Esophagus
1 other identifier
interventional
10
1 country
1
Brief Summary
Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to result in varying degrees of stenosis, especially if the resected area is large and/or circumferential. A new technique was described where autologous cells from the patients own oral mucosa are harvested and cultures on proprietary membranes (coated, temperature sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2018
CompletedOctober 24, 2023
October 1, 2023
6.2 years
May 20, 2015
October 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative stenosis
Development of an oesophageal stenosis that cannot be passed by a standard 9 mm endoscope
4 weeks
Study Arms (2)
ESD/EMR plus Cell Sheet
EXPERIMENTALPatients receive both mucosal buccal biopsy and insertion of cell sheets during/after ESD/EMR
ESD/EMR
SHAM COMPARATORpatients receive both mucosal biopsy but no placement of cell sheets during/after ESD
Interventions
Patients receive ESD/EMR plus CellSheet: Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane ("Cell Sheet") that are inserted 2 weeks later on the occasion of the ESD or EMR
only ESD/EMR: Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane ("Cell Sheet") but NOT used for insertion in the patient during/after ESD/EMR two weeks later
Eligibility Criteria
You may qualify if:
- Barrets esophagus, histologically confirmed, or early oesophageal cancer (both squamous and adeno)
You may not qualify if:
- no consent can be given
- prior ESD/EMR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Matthias Löhrlead
Study Sites (1)
Gastrocentrum, KarolinskaUniversity Hospital
Stockholm, 14186, Sweden
Related Publications (1)
Jonas E, Sjoqvist S, Elbe P, Kanai N, Enger J, Haas SL, Mohkles-Barakat A, Okano T, Takagi R, Ohki T, Yamamoto M, Kondo M, Markland K, Lim ML, Yamato M, Nilsson M, Permert J, Blomberg P, Lohr JM. Transplantation of tissue-engineered cell sheets for stricture prevention after endoscopic submucosal dissection of the oesophagus. United European Gastroenterol J. 2016 Dec;4(6):741-753. doi: 10.1177/2050640616631205. Epub 2016 Feb 19.
PMID: 28408991RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Magnus Nilsson, MD PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Gastroenterology & Herpetology
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 28, 2015
Study Start
January 1, 2012
Primary Completion
March 25, 2018
Study Completion
March 25, 2018
Last Updated
October 24, 2023
Record last verified: 2023-10